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Principal Scientist - Pathology

Company: Takeda Pharmaceuticals North America Inc
Location: Methuen
Posted on: September 12, 2020

Job Description:

Company: Takeda

Location: Cambridge

Posted on: August 16, 2020

Job Description:

By clicking the Apply button, I understand that my employmentapplication process with Takeda will commence and that I agree withTakedas Privacy Notice, Privacy Policy and Terms of Use.JobDescriptionAre you looking for a patient-focused, innovation-drivencompany that will inspire you and empower you to shine? Join us asa Principal Scientist - Pathology in our Cambridge office.

At Takeda, we are transforming the pharmaceutical industry throughour R&D-driven market leadership and being a values-ledcompany. To do this, we empower our people to realize theirpotential through life-changing work. Certified as a Global TopEmployer, we offer stimulating careers, encourage innovation, andstrive for excellence in everything we do. We foster an inclusive,collaborative workplace, in which our global teams are united by anunwavering commitment to deliver Better Health and a BrighterFutureto people around the world.

Here, you will be a vital contributor to our inspiring, boldmission.

OBJECTIVES:

Provide pathology and toxicology expertise and represent DSREon discovery, research and development project teams

Collaborate with Global Head of Pathology and Drug SafetyTherapeutic Leaders in the development and execution of strategiesfor discovery and development programs

Provide stewardship, toxicology and/or pathology support andinterpretation of toxicology studies on drug candidates withsubsequent preparation and review of regulatory documents andsupport of Regulatory Affairs and Clinical groups for all phases ofdevelopment, including IND through registration across alltherapeutic indications

Evaluate histopathology specimens from a variety of nonclinicalanimal species used in nonclinical toxicity studies to determinetarget organs and morphologic toxicity profile of potential novelpharmaceutical agents.

Conduct peer reviews of pathology data generated off-site.

Provide histopathology support for peripheral experimentalmodalities used in other departments such as immunohistochemistryand xenograft tumor models.

Serve on project teams for drug discovery, transition anddevelopment teams

Design and interpret toxicology studies to address human safetyconcerns and relevance

Review study reports and regulatory documents for technicalaccuracy and regulatory adequacy

Prepare regulatory documents (BB, IND, IB, DSUR, BLA, MAA, NDA,JNDA) and respond to health authorities concerning toxicologyissues

Collaborate and interface with project leaders across Takeda toensure transition of programs into development

Develop strategies for addressing toxicology issues and presentthem to management and governance committees

Work with Comparative Medicine in vivo toxicology group onissues regarding in vivo studies and the 3Rs

Participate in local and national toxicology/pathology meetingsand represent Takeda at these meetings

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

DVM (required) and PhD (preferred)

Proficiency in toxicologic pathology (3-5 years ofexperience)

Pharmaceutical drug development experience including as aproject team representative (preferred but not required)

In-depth understanding of molecular biology

Excellent communication skills (written and oral)

Ability and desire to take on leadership roles

Ability to team with colleagues across different functionalareas

Proficiency with computer systems such as word processing,spreadsheets and databases

LICENSES/CERTIFICATIONS:

Certification in veterinary pathology (ACVP, ECVP, orJCVP)

Certification in toxicology (ABT or equivalent) - optional

TRAVEL REQUIREMENTS:

Willingness to travel to various meetings or client sites,including overnight trips. Some international travel may berequired.

Requires approximately 5% travel.

WHAT TAKEDA CAN OFFER YOU:

401(k) with company match and Annual Retirement ContributionPlan

Tuition reimbursement Company match of charitablecontributions

Health & Wellness programs including onsite flu shots andhealth screenings

Generous time off for vacation and the option to purchaseadditional vacation days

Community Outreach ProgramsEmpowering Our People to Shine

Discover more at takedajobs.com

No Phone Calls or Recruiters Please.

#LI-KL1

LocationsCambridge, MAWorker TypeEmployeeWorker Sub-TypeRegularTimeTypeFull time

Keywords: Takeda, Waltham , Principal Scientist - Pathology, Healthcare , Cambridge, Massachusetts

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Keywords: Takeda Pharmaceuticals North America Inc, Methuen , Principal Scientist - Pathology, Other , Methuen, Massachusetts

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